An investigation on behalf of investors of Neovasc Inc. (NASDAQ: NVCN) shares over potential securities laws violations by Neovasc Inc. and certain of its directors and officers in connection with certain financial statements was announced.

The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Neovasc Inc. (NASDAQ: NVCN) concerning whether a series of statements by Neovasc Inc regarding its business, its prospects and its operations were materially false and misleading at the time they were made.

Canada based Neovasc Inc., a specialty medical device company, develops, manufactures, and markets medical devices for cardiovascular marketplace in Europe, the United States, and internationally.

On December 20, 2018, Neovasc Inc. filed a comprehensive Q-Sub submission to the FDA with all available evidence for its product Neovasc Reducer, including the prospective, multicenter, randomized, double-blind, sham controlled study assessing the safety and efficacy of the Reducer in 104 patients in the European Union and Canada (COSIRA), a multi-center, multi-country, three-arm observational post market study (REDUCER-I), and supportive safety and efficacy data from peer-reviewed journals.
On February 20, 2019, Neovasc Inc. announced that the FDA had informed Neovasc that, despite Breakthrough Device Designation, the FDA review team recommended collection of further pre-market blinded data prior to Pre-Market Approval submission.
On October 9, 2019, despite recommendations from the FDA to the contrary, Neovasc Inc. decided to pursue a PMA application for this Breakthrough medical device without gathering any further evidence. Thereafter, the Company made optimistic statements regarding the likelihood of approval, such as, the Company believes that the clinical evidence already available will be sufficient to not further delay the availability of this Breakthrough medical device for the treatment of U.S. patients.
On October 28, 2020, prior to markets opening, Neovasc Inc. announced that, although the FDA voted that the Reducer is safe when used as intended, they voted overwhelmingly against issuing a reasonable assurance of effectiveness and on whether the relative benefits outweighed the relative risks.

Shares of Neovasc Inc. (NASDAQ: NVCN) declined to as low as $0.87 per share on October 30, 2020.